Prescription drug · ANDA
Cimetidine NDC 50090-0500
Cimetidine 400 mg/1 · Tablet, Film coated · Oral · A-S Medication Solutions
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50090-0500-0 | 5009005000050090050000 | 30 TABLET, FILM COATED in 1 BOTTLE (50090-0500-0)Marketed from Jun 29, 2016 | |
| 50090-0500-1 | 5009005000150090050001 | 60 TABLET, FILM COATED in 1 BOTTLE (50090-0500-1)Marketed from Jul 26, 2016 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Cimetidine
- Generic name (nonproprietary)
- cimetidine
- Active ingredients
- Cimetidine — 400 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- A-S Medication SolutionsNDC labeler code 50090
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 074151
- Marketing start
- Listing expires
- Other FDA classes
- Histamine H2 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 50090-0500_ae5b3c50-f23b-465c-9a57-cbb92ddbd3b6SPL ID ae5b3c50-f23b-465c-9a57-cbb92ddbd3b6SPL set ID cf1626a1-ccf6-4759-b2ab-22c7f3873d84RxCUI 197506, 197507UNII 80061L1WGD
- Pharmacologic class
- Histamine-2 Receptor Antagonist
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N450090050000followed by a unit qualifier and the quantityPackage 50090-0500-00. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
INDICATIONS AND USAGE Cimetidine tablets USP are indicated in: Short-term treatment of active duodenal ulcer. Most patients heal within 4 weeks and there is rarely reason to use cimetidine at full dosage for longer than 6 to 8 weeks (see DOSAGE AND ADMINISTRATION , Duodenal Ulcer ). Concomitant antacids should be given as needed for relief of pain. However, simultaneous administration of oral cimetidine and antacids is not recommended, since antacids have been reported to interfere with the absorption of oral cimetidine. Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of active ulcer. Patients have been maintained on continued treatment with cimetidine 400 mg …
Excerpt only. Read the full label for complete information.
About NDC 50090-0500
- What is NDC 50090-0500?
- 50090-0500 is the product NDC for Cimetidine, Cimetidine 400 mg/1 tablet, film coated, listed with the FDA by A-S Medication Solutions. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Cimetidine.
- What is the active ingredient?
- Cimetidine.
- Who is the labeler?
- A-S Medication Solutions, NDC labeler code 50090. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Cimetidine?
- 21 other product NDCs are listed under this name. See all Cimetidine NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Cimetidine products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Cimetidine | Cimetidine 200 mg/1 | Tablet, Film coatedOral | Bionpharma Inc. | 69452-323 | 69452-0323-2069452-0323-30 |
| Cimetidine | Cimetidine 300 mg/1 | Tablet, Film coatedOral | Bionpharma Inc. | 69452-324 | 69452-0324-2069452-0324-30 |
| Cimetidine | Cimetidine 400 mg/1 | Tablet, Film coatedOral | Bionpharma Inc. | 69452-325 | 69452-0325-2069452-0325-30 |
| Cimetidine | Cimetidine 800 mg/1 | Tablet, Film coatedOral | Bionpharma Inc. | 69452-326 | 69452-0326-2069452-0326-30 |
| Cimetidine | Cimetidine 400 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 59651-825 | 59651-0825-0159651-0825-05 |
| Cimetidine | Cimetidine 800 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 59651-826 | 59651-0826-01 |
| Cimetidine | Cimetidine 400 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 51655-697 | 51655-0697-51 |
| Cimetidine | Cimetidine 400 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 63187-333 | 63187-0333-30 |
| Cimetidine | Cimetidine 800 mg/1 | Tablet, Film coatedOral | Teva Pharmaceuticals USA, Inc. | 0093-8305 | 00093-8305-01 |
| Cimetidine | Cimetidine 300 mg/1 | Tablet, Film coatedOral | Teva Pharmaceuticals USA, Inc. | 0093-8192 | 00093-8192-0100093-8192-05 |
Other NDCs under ANDA 074151
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Cimetidine | Cimetidine 300 mg/1 | Tablet, Film coatedOral | Teva Pharmaceuticals USA, Inc. | 0093-8192 |
| Cimetidine | Cimetidine 400 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 63187-333 |
| Cimetidine | Cimetidine 300 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 63629-1783 |